Resveratrol in Healthy Adult Participants

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Resveratrol may prevent cancer in healthy people. Studying samples of blood and urine in the laboratory from participants who are taking resveratrol may help doctors learn more about how this drug is used by the body. This phase I trial is studying the side effects of resveratrol and to see how it works in healthy adult participants.

I. To determine the modulation effect on phase II detoxification enzymes. II. To evaluate safety in participants treated with this drug.

OUTLINE:

Participants receive oral resveratrol once daily for 4 weeks.

Patients complete a daily diary documenting adverse events and an intake calendar for recording the daily intake of any non-routine medications.

Participants undergo blood sample collection periodically. Lymphocytes are isolated and analyzed for baseline GST activity and level. Serum is analyzed to determine bilirubin levels to be used as surrogate UGT 1A1 activity. Analyses of CYP probe drugs will be performed using high performance liquid chromatography (HPLC) assays. A sensitive ELISA assay will be used for quantitative analyses. Urine samples are collected periodically and drug and metabolite levels will be analyzed.

After completion of study treatment, participants are followed for 2 weeks.

Modulation of CYP enzyme activities [ Time Frame: From baseline to end of resveratrol intervention ]

Will be assessed by a comparison of CYP enzyme activities from baseline to end of resveratrol intervention. CYP1A2, 2D6, 2C9, and 3A4 activity will be assessed by plasma paraxanthine/caffeine ratio, urinary dextromethorphan/dextrophan ratio, urinary losartan/losartan metabolite ratio, and area under the plasma buspirone concentration-time curve, respectively. The primary analysis will consist of paired t-tests of differences in log values from baseline to end of intervention (equivalent to log of the ratio).

Secondary Outcome Measures :

Changes in Phase II enzyme activity [ Time Frame: From baseline to end of resveratrol intervention ]

GST activity and GST-pi level in blood lymphocytes and serum bilirubin levels will be used to assess Phase II enzyme activity. Paired t-tests of differences in values from baseline to end of intervention will be used, with a 2-sided significance level of 0.0167 for the three tests.

Safety evaluation using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 [ Time Frame: Up to 6 weeks ]

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Layout table for eligibility information

Ages Eligible for Study:

18 Years and older (Adult, Older Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Criteria:

Healthy adult participants meeting the following criteria:

Limit cruciferous vegetables to no more than one serving each week for about 6 weeks

Limit resveratrol-containing foods (i.e., wine, peanuts, mulberries, grapes, cranberries, blueberries, and huckleberries) to no more than one serving each per day for about 6 weeks

No caffeine-containing food or beverages (e.g., coffee, colas, chocolate, or over-the-counter medications) or food items that have been reported to affect drug/carcinogen metabolizing enzymes (e.g., grapefruit, grapefruit juice, cruciferous vegetables, and food cooked over charcoal) beginning 72 hours before and until 8 hours after each set of CYP probe drug administration

Leukocytes >= 3,000/uL

Absolute neutrophil count >= 1,500/uL

Platelet count >= 100,000/uL

Total bilirubin =< 2.0 mg/dL

AST/ALT =< 1.5 times upper limit of normal (ULN)

Creatinine =< ULN

Not pregnant or nursing

Negative pregnancy test

Fertile patients must use effective contraception

Must have a resting systolic blood pressure >= 100 mm Hg at screening and prior to probe drug administration

Must not consume more than three drinks of alcohol per week on average

No prior invasive cancers (i.e., non-skin cancer) within the past 5 years

No history of allergic reactions to resveratrol-containing products or CYP probe drugs (e.g, caffeine, dextromethorphan, losartan, or buspirone)

No uncontrolled intercurrent illness including, but not limited to, any of the following:

Ongoing or active infection

Symptomatic congestive heart failure

Unstable angina pectoris

Cardiac arrhythmia

Psychiatric illness or social situation that would limit compliance with study requirements

No over-the-counter medications beginning 72 hours before and until 8 hours after each CYP probe drug administration

No participation in another clinical intervention trial within the past 3 months

No concurrent medications or supplements that are known CYP enzyme inducers or inhibitors